Link Between Low Level Cadmium Exposure And Lung Disease

New research suggests that cadmium is one of the critical ingredients causing emphysema, and even low-level exposure attained through second-hand smoke and other means may also increase the chance of developing lung disease.

The University of Michigan School of Public Health study suggests that higher cadmium levels in the body as much as double the risk of developing a pulmonary disease diagnosis such as emphysema or chronic bronchitis.

Though some studies have linked high levels of cadmium with decreased lung function in occupationally exposed workers, this is only the second known study to show that subjects with even slightly increased levels of cadmium had decreased lung function and the first known study to do so using repeated measures of lung function over time.

“The study suggests that the critical ingredient in smoking that may be causing emphysema is cadmium, a well-known contaminant of cigarette smoke,” said Howard Hu, professor at the U-M School of Public Health and principal investigator in the study. “The worry is if you are exposed to this (cadmium) through other sources you can also be at risk for emphysema.”

Non-smokers are exposed to cadmium when they eat contaminated foods or inhale second-hand smoke, as well as through a host of occupational exposures. Cadmium is a metal that is difficult for the body to dispel, Hu said, because kidneys tend to retain cadmium, and it recycles into the body.

Cadmium has received its share of media attention, and some consumer groups are concerned about cadmium in sludge and crop fertilizers. It is also widely used in batteries and pigments.

“The big picture is, we keep learning more about the contributions of environmental toxins to the chronic diseases of aging for which we never suspected an environmental cause,” said Hu, who is also chair of the School of Public Health Department of Environmental Health Sciences and has an appointment with the Medical School.

The study looked at 96 men randomly selected from within the Normative Aging Study, a project that began in 1961 and includes approximately 2,280 healthy, male volunteers from Boston, Mass.

Researchers tested lung function using three different measures. Subjects with higher levels of urinary cadmium showed evidence of a reduced ability to exhale, irrespective of whether they smoked but with an effect that was greatest and clearest among current and former smokers.

The next step is a much larger, population-based study with more subjects and multiple measurements of cadmium exposure and lung function over time, Hu said.

“With a larger population we will be able to better disentangle the independent effects of cadmium and smoking, and whether dietary cadmium or other non-cigarette sources may also influence lung function,” Hu said.

Sung Kyun Park, research assistant professor in the U-M School of Public Health, was second author and supervised the analysis of data. The paper, “Association Between 24-hour Urinary Cadmium and Pulmonary Function Among Community-Exposed Men: The VA Normative Aging Study.” Click here to access the study which is scheduled for the September issue of the journal Environmental Health Perspectives.

For more on Hu: click here.

For more on the School of Public Health: click here.

The University of Michigan School of Public Health has been working to promote health and prevent disease since 1941, and is consistently ranked among the top five public health schools in the nation. Faculty and students in the school’s five academic departments and dozens of collaborative centers and initiatives are forging new solutions to the complex health challenges of today, including chronic disease, health care quality and finance, emerging genetic technologies, climate change, socioeconomic inequalities and their impact on health, infectious disease, and the globalization of health.

Source: Laura Bailey

University of Michigan

Moving 2 Steps Closer To Understanding The Genetic Underpinnings Of Autism

The latest issue of the American Journal of Human Genetics (AJHG), describes what might be a corner piece of the autism puzzle – the identification and subsequent validation of a gene linked to the development of autism by three separate groups of scientists. An accompanying commentary by Dr. Dietrich Stephan, Director of the Neurogenomics Division at the Translational Genomics Research Institute’s (TGen), further explains the findings.

Autism is a perplexing disease whose cause remains unexplained. It has long been suggested that environmental factors, linked with genetics, play a role in causing the disorder. As recently as last week, researchers in California published a study that found no proof linking autism with a mercury-based preservative found in childhood vaccines. While there are no clear-cut answers, researchers are one step closer to understanding autism’s genetic cause.

In March 2006, Dr. Stephan, Director of TGen’s Neurogenomics Division, led a team of researchers at TGen and collaborators at the Clinic for Special Children (CSC) in Strasburg, PA, that identified a gene called CNTNAP2. When mutated, this gene indicated a predisposition to autism in a specific population of Old Order Amish children from Pennsylvania.

One of the most important principles in science is the ability to replicate results. Now, three groups of researchers from Yale University, the University of California, Los Angeles, and the Johns Hopkins University, have replicated the initial finding in the general population, unequivocally implicating this gene as causing the newly defined Type 1 autism. All three studies plus Dr. Stephan’s commentary are published in the January edition of AJHG.

According to Dr. Erik Puffenberger, Laboratory Director of the Clinic for Special Children, “Our previous finding of association between loss of CNTNAP2 function and autistic behavior has been validated in the general population. This is a very exciting step for autism research. It also highlights the enormous potential of the ‘small science’ approach. Our initial work used only four affected Amish children. Careful study of these four patients uncovered the association between CNTNAP2 and autistic behaviors. From that small beginning, CNTNAP2 has now been implicated as a significant risk factor for autism.”

Autism spectrum disorder (ASD) is a broadly used term for a set of developmental disorders that emerges in infants and young children. ASD impairs a child’s intuitive thought, language and social development to varying degrees. Most individuals diagnosed with ASD require lifelong supervision and care; the most severely affected are unable to speak. ASD is the fastest growing developmental disability in the U.S. Two decades ago, roughly one child in 10,000 was diagnosed with ASD; it now affects one in 150 births.

“The field of genetics is replete with examples where researchers are unable to reproduce results. Here we have independent confirmation in multiple groups using large samples sizes,” said Dr. Stephan. “Now that the results of the initial CNTNAP2 gene finding have been replicated, it strongly supports the notion that the ‘broken version’ of CNTNAP2 is recognized as a cause of autism in the general population.”

In collaboration with the Phoenix-based Southwest Autism Research & Resource Center (SARRC), a nonprofit community-based organization dedicated to research, education and resources for individuals with ASDs and their families, TGen will apply these research findings to children in Arizona who have been diagnosed with ASD.

“The heterogeneity of the disorder has frustrated our past efforts in the search for causes of autism,” said Dr. Raun Melmed, medical director and co-founder of SARRC. “This exciting discovery will further our capacity to individualize approaches to the diagnosis and treatment of autism.”

The next step, noted Dr. Stephan in the commentary, is to develop a diagnostic to test for the CNTNAP2 mutation. If physicians could implement behavioral interventions early enough, children with autism may have a better chance of developing normally.

The initial discovery of CNTNAP2 in autism was published in the March 30, 2006, issue of the New England Journal of Medicine.

About TGen

The Translational Genomics Research Institute (TGen) is a non-profit 501(c)(3) organization focused on developing earlier diagnostics and smarter treatments. Translational genomics research is a relatively new field employing innovative advances arising from the Human Genome Project and applying them to the development of diagnostics, prognostics and therapies for cancer, neurological disorders, diabetes and other complex diseases. TGen’s research is based on personalized medicine. The institute plans to accomplish its goals through robust and disease-focused research.

About the Clinic For Special Children

The Clinic for Special Children was established in 1989 to provide early diagnosis, affordable laboratory services, and comprehensive medical and nutritional care for Old Order Amish and Mennonite children that suffer from genetic disorders. The clinic mission encompasses four aims: 1) Make high-quality medical care for special children accessible, affordable, and culturally effective; 2) Develop comprehensive methods of newborn screening and follow-up care for genetic disorders prevalent among the Plain people; 3) Develop practical clinical applications for modern molecular genetic technologies; and 4) Elucidate disease mechanisms for the purpose of improving patient treatment and outcome. Clinical work at the CSC is funded by private donations from individuals, foundation contributions, and an endowment fund established for this purpose. Many collaborating scientists and laboratories donate specialized services. The CSC receives no money from state or federal sources and is a private non-profit 501(c)(3) charitable institution.

About SARRC

Founded in 1997, the Southwest Autism Research & Resource Center (SARRC) is a nonprofit, community-based organization dedicated to autism research, education and resources for children and young adults with autism spectrum disorders (ASDs) and their families. SARRC undertakes self-directed and collaborative research projects, serves as a satellite site for national and international projects, and provides up-to-date information, training and assistance to families and professionals about ASDs. For more information about SARRC, visit autismcenter/.

Source: Amy Erickson

The Translational Genomics Research Institute

Blue Cross And Blue Shield Of Oklahoma Announces Autism Benefits

Blue Cross and Blue Shield of Oklahoma announced the addition of an autism benefit to insured groups effective their next policy year. This change will not in any way affect the current medical coverage that has always been available to children with autism. Blue Cross and Blue Shield of Oklahoma is responding to market interests in the benefits and coverage of certain autism-related medically necessary services.

“We want to commend the Oklahoma Legislature for allowing the market to work,” said Bev Binkowski, director, public affairs. “Rather than having a ‘one-size-fits-all’ mandate for all companies, we have been able to develop a benefit to meet the needs of our members.”

Blue Cross and Blue Shield of Oklahoma will provide “a clinically reasonable benefit that doesn’t unduly create a price impact on small employer groups and affect their ability to provide health care coverage to their employees,” said Dr. Joe Nicholson, Blue Cross and Blue Shield of Oklahoma’s chief medical officer and vice president of health care management. Benefit enhancements are expected to include evaluation and management procedures, speech, physical and occupational therapies. The health plan is targeting a January 2010 implementation date for this new benefit.

“Blue Cross and Blue Shield of Oklahoma has been able to develop a benefit that won’t dramatically increase premiums,” Binkowski said. “This decreases the likelihood that the increased benefit will result in employers dropping coverage and adding to the state’s uninsured population.”

“This action will allow us to provide a benefit for proven therapeutic services while research continues to identify effective treatments or medical solutions for children with autism,” Nicholson said.

Blue Cross and Blue Shield of Oklahoma is a member of the Affordable Access to Health Care coalition. For more information, visit affordableaccesstohealthcare.

Blue Cross and Blue Shield of Oklahoma
bcbsok

Important New Rheumatology Resource Unveiled

A comprehensive account of the most important advances in rheumatology research from the past decade has been published in BioMed Central’s open access journal Arthritis Research and Therapy (AR&T). This freely available collection of 38 articles an internationally recognized group of experts spanning more than 400 pages is an essential educational tool which provides clinicians and researchers with a detailed overview of the current status of basic, translational and clinical research in rheumatology.

Rheumatic diseases affect the body’s joints, muscles, skin and a variety of internal organs and connective tissues. Current estimates indicate that some 43 million Americans have been diagnosed to date as well as even greater numbers worldwide. AR&T’s new review collates the expertise of 39 renowned scientists and rheumatologists to present physicians and scientists around the globe with an invaluable reference work outlining the biologic processes underlying rheumatic diseases and analyzing the most significant developments in specific rheumatic diseases from the past decade.

“The past ten years have seen an explosion of new information in rheumatology research” said Arthritis Research and Therapy Editors-in-Chief, Peter E Lipsky and Ravinder N. Maini. “This collection produced for AR&T’s 10th anniversary will help readers around the world understand the nature of the new developments that not only should stimulate additional interdisciplinary research on unsolved problems but also foster the timely application of this new knowledge into better patient care.”

Source: BioMed Central Limited

Novavax Announces Preclinical Data For Respiratory Syncytial Virus Vaccine Candidate

Novavax, Inc. (Nasdaq: NVAX) announced that Dr. Trudy Morrison, PhD, Professor of Molecular Genetics and Microbiology, University of Massachusetts Medical School, will be presenting the results of a preclinical study of a vaccine candidate for the prevention of respiratory syncytial virus (“RSV”) at the 2nd Vaccine Congress in Boston, MA on December 9, 2008. This study was funded by Novavax, Inc., which has exclusive rights to develop and commercialize Paramyxovirus vaccines incorporating certain Virus-Like-Particles (VLPs) under a licensing agreement with the University of Massachusetts Medical School.

About Novavax

Novavax, Inc. is a clinical stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide using advanced proprietary virus-like particle (VLP) technology. The Company produces these VLP based, potent, recombinant vaccines utilizing new, and efficient manufacturing approaches. Additional information about Novavax is available at novavax and in the Company’s various filings with the Securities and Exchange Commission.

Forward Looking Statement

Statements herein relating to future development results and performance, conditions or strategies and other matters, including expectations regarding product and clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks relating to the early stage of Novavax’s product candidates under development; current results may not be predictive of future pandemic results, results of our seasonal influenza vaccine or any other vaccine that we may develop; further testing is required before regulatory approval can be applied for and the FDA may not approve a vaccine even if further trial results are similar to those disclosed previously by the company; uncertainties relating to clinical trials; dependence on the efforts of third parties; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; and risks that we may lack the financial resources and access to capital to fund our operations including further clinical trials. Further information on the factors and risks that could affect Novavax’s business, financial conditions and results of operations, is contained in Novavax’s filings with the U.S. Securities and Exchange Commission, which are available at sec. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.

Novavax, Inc.
novavax

Treatment Of Asthma: Stepping Up Treatment And Also Stepping It Down

Asthma symptoms vary greatly among individuals and vary at times with each individual. In this comprehensive study in the April issue of Mayo Clinic Proceedings, researchers address the prevalence and process of step-down therapy as symptoms subside. Of the 397 adults and children studied, 64 percent had at least one change in medication dose during the two years of the study. Most changes were step-up in doses during an asthma flare. Step-down changes were far less common.

Lead author Barbara Yawn., M.D., from the Department of Research at Olmsted Medical Center in Rochester, Minn., comments that “patients indicate it is important to them to take the lowest possible dose of medication to maintain asthma control, suggesting we need to step down therapy when feasible.”

This is one of the first studies to address the frequency, type and context of step-up and step-down changes in asthma therapy for children and young adults. The study asserts that asthma care continues to be episodic, with most physician visits occurring at a flare-up. Additional research will help determine the best course of long-term treatment for patients with asthma.

Other study authors are Peter Wollan, Ph.D., and Susan Bertram, also from the Department of Research at Olmsted Medical Center; David Lowe, M.D., and Denise Bonde, M.D., from the Department of Allergy and Asthma at Olmsted Medical Center; and Joseph Butterfield, M.D., and James Li, M.D., Ph.D., from the Division of Allergic Diseases at Mayo Clinic in Rochester.

This study was funded by a grant from Integrated Therapeutics and the National Institutes of Health.

A peer-review journal, Mayo Clinic Proceedings publishes original articles and reviews dealing with clinical and laboratory medicine, clinical research, basic science research and clinical epidemiology. Mayo Clinic Proceedings is published monthly by Mayo Foundation for Medical Education and Research as part of its commitment to the medical education of physicians. The journal has been published for more than 80 years and has a circulation of 130,000 nationally and internationally. Articles are available online at mayoclinicproceedings/.

To obtain the latest news releases from Mayo Clinic, go to mayoclinic/news. MayoClinic (mayoclinic/) is available as a resource for your health stories.

Contact: John Murphy
Mayo Clinic

Brain Made More Vulnerable To Strokes By Bottleneck In Blood Supply

A team of UC San Diego physicists and neuroscientists has discovered a bottleneck in the network of blood vessels in the brain that makes it vulnerable to strokes. The finding may explain the origin of the puzzling damage to the brain??™s gray matter often detected in brain scans, especially among the elderly.

In the study, published this week in the journal Proceedings of the National Academy of Sciences, the researchers used a laser technique they developed to precisely monitor changes in blood flow resulting from an induced blockage in a tiny artery, or arteriole, in the brains of anesthetized rats. They found that the penetrating arterioles, which connect the blood vessels on the brain??™s surface with deeper blood vessels, are a vulnerable link in the network.

“The blood vessels on the surface of the brain are like a collection of city streets that provide multiple paths to get somewhere,” explained David Kleinfeld, a professor of physics at UCSD, who led the team. “If one of the vessels is blocked, blood flow quickly rearranges itself. On the other hand, the penetrating arterioles are more like freeways. When blocked, the blood flow is stopped or slowed significantly in a large region round the clot.”

The obstruction of blood flow resulted in damage to the surrounding brain area, which the researchers report resembled damage seen in the brains of humans and thought to be the result of “silent strokes.” Silent strokes have attracted attention recently because magnetic resonance imaging has made it possible to follow changes in the brains of individuals as they age. MRI scans have revealed that, over time, small holes accumulate in the gray matter of many patients, including those who have no obvious behavioral signs of a stroke.

The researchers say their results support the hypothesis, made by clinicians, that the penetrating arterioles may be the location of small strokes that cause the death of sections of brain tissue in humans. The accumulation of damage may lead to memory loss, and may be a risk factor for having a larger stroke, according to Pat Lyden, a professor of neurosciences at UCSD??™s School of Medicine and head of the UCSD Stroke Center.

“This damage is an enormous problem,” said Lyden, who collaborated with Kleinfeld on the study. “We think it is part of the dementia picture in Alzheimer??™s and non-Alzheimer??™s patients. But until now, we had no insight into the mechanism of the damage, and understanding the mechanism is the first step toward understanding how to prevent it.”

To determine what happens in the brain during a stroke, the researchers created a tiny clot in a blood vessel in the brain of an anesthetized rat. They used focused laser light to excite a dye they had injected into the bloodstream. A chemical reaction of the excited dye “nicked” the blood vessel at the target location and triggered the natural clotting response.

“The technique creates a clot while generating very little collateral damage,” said Beth Friedman, an associate project scientist working with Lyden in neurosciences and a contributing author on the paper. “Then we can study blood flow changes to understand what is happening in the brain in real time.”

Before and after the formation of the clot, the researchers tracked the movements of red blood cells using two-photon fluorescence microscopy. Two-photon fluorescence microscopy is a powerful imaging tool that uses brief (less than one-trillionth of a second) laser pulses to peer below the surface of the brain.

In contrast to a previous study, in which the team showed there was very little disruption in blood flow when a clot formed in the blood vessels on the surface of the brain, a blockage in the penetrating arterioles had a significant effect. The flow of red blood cells was reduced far downstream of the blockage. Because blood flow cannot simply take alternate routes to compensate for the blockage, the penetrating arterioles are a bottleneck in the blood supply to gray matter.

“In this study, we took advantage of being able to see into individual capillaries in brain tissue,” explained Nozomi Nishimura, who was a graduate student working with Kleinfeld in physics at the time of the study. “It is the capillaries, the smallest blood vessels, that provide the brain cells with oxygen and nutrients. So we were able to measure the dynamics of blood flow where it really matters to nerve cells.”

Nishimura was the first author on the study and is now a postdoctoral fellow at Cornell University working with Chris Schaffer, an assistant professor of biomedical engineering. Schaffer, who also contributed to the study, was an assistant project scientist working with Kleinfeld and Lyden at the time of the discovery.

The study was supported by the National Institutes of Health and the National Science Foundation.

Contact: Sherry Seethaler

University of California – San Diego

Respirology Editor Honored For Work In Respiratory Medicine

Editor-in-Chief of Respirology, Professor Philip Thompson, was conferred the highest award the Asia Pacific Society of Respirology (ASPR) can possibly offer – the inaugural ASPR Society Medal.

Conceived by the ASPR – one of the largest respiratory societies in the world -the Medal was awarded to Professor Thompson in recognition of his significant contributions to the practice of respiratory medicine in the Asia Pacific region, his efforts in turning Respirology into a world leading journal as well as for his 10 years of service on the ASPR’s Executive committee.

This inaugural award was presented to Professor Philip Thompson, Director of the Lung Institute of Western Australia (LIWA) at the Annual Conference of APSR in Bangkok recently.

Professor Thompson said, “I am extremely honored to be given such an award that reflects the views of my peers whom I value and admire so much. I am also very conscious that there are many other deserving individuals who have worked so hard for the APSR and respiratory medicine in the region who equally deserve public recognition”.

Based at Sir Charles Gairdner Hospital in Nedlands, Western Australia, LIWA researches treatment of respiratory and allergic diseases. Dr. Lieve Bultynck, manager of the editorial office of Respirology said, “LIWA and all of the editorial staff at Respirology are delighted with Professor Thompson’s award as it pays tribute to all the hard work involved in running the Journal. It also recognizes the importance of having a publisher like Wiley-Blackwell who has been so supportive of all our endeavours.

About the Asia Pacific Society of Respirology (ASPR)

The APSR is one of the largest respiratory societies worldwide with 13,000 members. It has grown in considerable stature over the last 8 years. It represents all of the countries in the Asia Pacific Region with its key membership base being made up of members of the Japanese, Taiwanese, Korean, Philippine and Australian and New Zealand Thoracic Societies. Other countries involved include Thailand, Singapore, Malaysia, Bangladesh, Hong Kong and China. The APSR is one of only six members of the Federation of International Respiratory Societies.

About Respirology

Respirology is a journal of international standing, publishing peer-reviewed articles of scientific excellence in clinical and experimental respiratory biology and disease and its related fields of research including thoracic surgery, internal medicine, immunology, intensive and critical care, epidemiology, cell and molecular biology, pathology, pharmacology and physiology.

About Wiley-Blackwell

Wiley-Blackwell was formed in February 2007 as a result of the acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with Wiley’s Scientific, Technical, and Medical business. Together, the companies have created a global publishing business with deep strength in every major academic and professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peer-reviewed journals and an extensive collection of books with global appeal. For more information on Wiley-Blackwell, please visit blackwellpublishing or interscience.wiley.

About Wiley

Founded in 1807, John Wiley & Sons, Inc. has been a valued source of information and understanding for 200 years, helping people around the world meet their needs and fulfill their aspirations. Since 1901, Wiley and its acquired companies have published the works of more than 350 Nobel laureates in all categories: Literature, Economics, Physiology/Medicine, Chemistry and Peace.

Our core businesses include scientific, technical, medical and scholarly journals, encyclopedias, books, and online products and services; professional/trade publishes books, subscription products, training materials, and online applications and websites; and educational materials for undergraduate and graduate students and lifelong learners. Wiley’s global headquarters are located in Hoboken, New Jersey, with operations in the U.S., Europe, Asia, Canada, and Australia. The Company’s Web site can be accessed at wiley. The Company is listed on the New York Stock Exchange under the symbols JWa and JWb.

Wiley

Asthma – Can Reducing Salt Intake Help?

A new study, funded by Asthma UK, carried out at Nottingham University, UK, will look at the effects of a reduced salt diet on people with asthma. Team leader will be Dr. Andrew Fogarty.

If findings indicate this is so, there will be more justification for a public health intervention to lower the amount of salt people consume nationally.

Recent studies have indicated that people with asthma who consume a lot of salt benefit from a lower intake – especially exercise-induced asthma, according to a recent US study.

This new study will look at how sodium restriction can control asthma generally. Dr. Fogarty said ‘If this proves beneficial then a low salt diet is an easy and simple way to help improve asthma symptoms. This could represent a huge advance in the management of this common condition.’

Dr Fogarty and his team will study 220 volunteers, all of them have asthma. They will be given a salt-reduced diet. Then they will be divided into two groups. One will carry on, on the low salt diet, while the other will be on a diet containing the UK national average salt intake. The trial will last six weeks. The aim will be to see if asthma levels and frequency are any different between the two groups during and at the end of the period.

Dr Lyn Smurthwaite, Asthma UK’s Research Development Manager, said ‘Reducing salt in our diets is thought to be beneficial for many reasons, and the possibility that it may improve asthma symptoms is something Asthma UK is keen to explore. We are delighted to fund Dr Fogarty’s work which may result in an additional asthma management option for some people with asthma.’

National Salt Awareness Week runs in the UK this year from 28 January – 3 February.

Asthma UK

:

Phase III Study Showed Rituxan® Decreased The Progression Of Joint Damage In Patients With Early Rheumatoid Arthritis

Genentech, Inc. (NYSE:DNA) and Biogen Idec (Nasdaq:BIIB) announced today that a Phase III clinical study of Rituxan® (rituximab) in patients with early rheumatoid arthritis (RA) who have not previously been treated with methotrexate (MTX) met its primary endpoint.

In this study, known as IMAGE, patients received two infusions of either 500 mg or 1000 mg of Rituxan or placebo for up to two treatment courses in combination with a stable dose of MTX. At week 52, only patients in the 1000 mg treatment group met the primary endpoint and showed significantly less progression of joint damage compared to patients who received placebo in combination with MTX. Joint damage was assessed by changes in X-ray images using the Genant-modified total Sharp score.

In both Rituxan treatment groups, secondary endpoints showed a significantly higher proportion of patients with a substantial improvement in RA signs and symptoms (including ACR scores and DAS remission) compared to patients receiving MTX alone. Further analyses of the data are ongoing and will be submitted for presentation at an upcoming medical meeting.

“The study results with Rituxan plus methotrexate in this early RA population are important because the majority of joint damage — a leading cause of disability in patients with RA — is believed to occur within the first two years of the disease, often before traditional disease-modifying drugs like methotrexate have been prescribed,” said Hal Barron, M.D., Genentech’s senior vice president, Development and chief medical officer. “The results from IMAGE reinforce our belief that B cells play an important role in the underlying disease process in RA.”

“The IMAGE study results provide further support for initiating a B-cell targeted agent earlier in RA treatment,” said Evan Beckman, M.D., Biogen Idec’s senior vice president of Immunology Research and Development. “The study results also confirm Rituxan’s positive impact on disease activity and physical function in RA patients. We look forward to sharing the full data set with the medical community and the FDA.”

The safety profile of Rituxan was consistent with our previous experience and a preliminary analysis did not reveal any new or unexpected safety signals. The incidence of adverse events and serious adverse events including infections and serious infections were comparable between Rituxan and placebo treatment groups. The companies continue to monitor the long-term safety of Rituxan treatment.

About the IMAGE Study

IMAGE is a multi-year, Phase III, randomized, double-blind, placebo-controlled, parallel group, multicenter international study designed to evaluate the safety and efficacy profile of Rituxan in combination with a stable dose of MTX compared to MTX alone, in methotrexate-na??ve patients with active rheumatoid arthritis. Methotrexate is a commonly used disease-modifying, anti-rheumatic drug (DMARD). The primary objective of the study was to determine the efficacy of Rituxan in the prevention of progression of structural joint damage and to evaluate the safety of Rituxan in patients with active, early rheumatoid arthritis initiating treatment with MTX.

A total of 755 MTX-na??ve patients with active RA from 168 study sites across 27 countries were randomized to receive either Rituxan (500 mg or 1000 mg) or placebo by intravenous infusion on days 1 and 15, in addition to therapy with MTX. Eligible patients who were not in DAS28-ESR remission 24 weeks following their previous course received a further course of RTX with the same dose as the first course. The primary endpoint evaluating change in total Genant-modified total Sharp scores was measured at week 52.

About Rheumatoid Arthritis (RA)

RA is a debilitating autoimmune disease that affects an estimated 1.3 million Americans and hinders daily activities. The damage that occurs in RA is a result of the immune system attacking joint tissue, causing painful chronic inflammation and irreversible destruction of cartilage, tendons and bones, which often results in disability. Common RA symptoms include inflammation of the joints, swelling, fatigue, stiffness and pain. Additionally, since RA is a systemic disease, it can affect other tissues such as the lungs and eyes.

About Rituxan®

Rituxan, discovered by Biogen Idec, is a therapeutic antibody that first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B cell non-Hodgkin’s lymphoma. It was also approved in the European Union under the trade name MabThera® in June 1998. Rituxan received FDA approval in February 2006 for the treatment of diffuse large B-cell lymphoma (DLBCL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens in previously untreated patients.

In February 2006, Rituxan also received FDA approval in combination with MTX to reduce signs and symptoms in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF antagonist therapies. In January 2008, Rituxan was approved to slow the progression of structural damage in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF-antagonist therapies. Rituxan is the first treatment for RA that selectively targets immune cells known as CD20-positive B cells. Rituxan does not target the entire immune system.

CD20 is not found on stem cells, pro-B cells (B cell precursors), normal plasma cells, or other normal tissues. Rituxan does not target plasma cells. These cells make antibodies that help fight infections.

Rituxan does not target stem cells in the bone marrow, and B cells can usually regenerate and gradually return to normal levels after retreatment with Rituxan in about 12 months for most patients.

In addition, Rituxan received FDA approval in September 2006 for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine, and prednisolone) chemotherapy and also for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.

Over the past ten years, there have been more than 1 million patient exposures to Rituxan.

Rituxan is also being studied in other autoimmune diseases with significant unmet medical needs, including lupus nephritis and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

Rituxan Safety

Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML).

Hepatitis B reactivation with fulminant hepatitis, other viral infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation have also been observed. Patients should be closely observed for signs of infection if biologic agents and/or disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate are used concomitantly.

The most common adverse reactions in Rituxan-treated RA patients are hypertension, nausea, upper respiratory tract infection, arthralgia, pruritus, and pyrexia.

The most common adverse reactions (incidence ?‰? 25 %) in Rituxan-treated NHL patients are infusion reactions, fevers, chills, infection, asthenia, and lymphopenia.

For additional safety information, please see full prescribing information, including Boxed Warnings and Medication Guide available at 1-800-821-8590 or gene

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines for patients with significant unmet medical needs. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit gene.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec’s significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit biogenidec

View drug information on Rituxan.